PPTA Regulatory Contributions

cfr31PPTA issues several types of documents to regulatory agencies as needed. The following represents all official regulatory communications by the Association organized by geography, regulatory body, and type of document. Additionally, since all regulations affect either  plasma collection or therapies, the documents are categorized as either source plasma or final therapies. The majority of PPTA's regulatory work is conducted in the European Union and the United States, but issues also are addressed in the rest of the world on an as-needed basis.

 

 

The three types of documents are:

1. Comments—in response to a regulatory body’s request for comments, often on a draft guidance document or proposed rule, in some cases following a public hearing, meeting or workshop

2. Letters—often addressed to a specific person and generally used to highlight an issue raised in a public forum or during liaison activities with regulators

3. Statements—written documentation of comments made orally at a public hearing and submitted to the docket in response to a regulator’s request for comments, or papers submitted to a regulator with or without a request


European Union

Source Plasma

Final Therapies

European Commission Directorate General for Health and Consumers (DG SANCO)

Comments to the European Commission

Position Papers to the European Commission

European Medicines Agency


United States

Source Plasma

Comments

Letters to FDA

Statements to FDA (Advisory Committee)

Final Therapies

Comments to FDA

Statements to FDA (Advisory Committee)


Rest of World